Standard Maintenance Therapy (SMT) vs Local Consolidative Radiation Therapy and SMT in OM-NSCLC

NCT05278052 | Recruiting Phase 3 DMC

• 2 other identifiers: 3445CTRI/2020/04/024761
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

Standard Maintenance Therapy versus Local Consolidative Radiation Therapy and standard maintenance therapy in 1-5 sites of OligoMetastatic Non-small cell lung cancer (NSCLC): A Phase III Randomized Controlled Trial

Conditions

Oligometastatic Disease; Metastatic Non Small Cell Lung Cancer

Keywords

Local Consolidative Radiation Therapy; Oligometastatic disease; NSCLC; Maintenance therapy; SABR

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  Overall survival is defined as the duration between the date of randomization to the date of death due to any cause or the date of last follow-up, whichever is earlier.

  Upto 2 years

Secondary Outcomes (7)

• Progression free survival (PFS )

  Upto 2 years

• Local control rates of treated sites

  Upto 2 years

• New distant metastases

  Upto 2 years

• Health Related QOL using the EORTC-QLQ-C30 questionnaire

  From randomization every 3 months till 2 years

• Health Related QOL using the EORTC- LC13 questionnaire

  From randomization every 3 months till 2 years

Study Arms (2)

ARM A: Standard maintenance therapy alone

ACTIVE COMPARATOR

Maintenance systemic therapy/ observation

Drug: Standard maintenance therapy as decided by the treating medical oncologist

ARM B: Local consolidative radiation therapy (LCRT)

EXPERIMENTAL

Radiation therapy to all oligometastatic sites including primary loco-regional disease

Radiation: Local consolidative radiation therapy; Drug: Standard maintenance therapy as decided by the treating medical oncologist

Interventions

Local consolidative radiation therapy RADIATION

Local consolidative radiation therapy (LCRT) to all oligo-metastatic sites in addition to primary disease site

Also known as: LCRT

ARM B: Local consolidative radiation therapy (LCRT)

Standard maintenance therapy as decided by the treating medical oncologist DRUG

Standard maintenance therapy/Observation

ARM A: Standard maintenance therapy alone; ARM B: Local consolidative radiation therapy (LCRT)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Patients with ECOG performance status of 0-2
• Patients with pathologically proven diagnosis of NSCLC
• Patients with 1-5 sites of metastatic disease not including the primary tumor and regional nodes (less than or equal to 3 metastatic lesions in one organ will be eligible and 4 or more metastatic lesions in one organ will be ineligible)
• Patients who have received standard duration of systemic therapy (4 - 6 cycles) without progression of the disease
• Patients suitable for definitive therapy to the primary disease
• All the Oligometastases lesions should be radiologically visible and suitable for ablative doses of radiation in accordance with the dose fractionation regimens specified in the protocol.
• Patients who have received ablative radiation therapy or surgery or RFA for metastatic sites at presentation or during systemic therapy will be eligible provided the total number of oligometastatic sites at the time of study entry (treated site included) is less than or equal to five.
• Patients who have received palliative RT for symptomatic bony metastases or RFA will also be eligible provided the treated site is under control on imaging. If not controlled, could be eligible for study if further ablative doses of radiation can be delivered according to the treating physician.
• Patients who underwent surgical decompression, or stabilization followed by palliative radiation therapy for bony metastases will be eligible in the study provided the treated site is under control on imaging and patient has less than 5 sites of metastases at the time of study entry.
• Adequate end organ function CBC/differential obtained within 15 days prior to registration on study, with adequate bone marrow function defined as follows:
• Absolute neutrophil count (ANC) ≥ 500 cells/mm3;
• Platelets ≥ 50,000 cells/mm3;
• Hemoglobin ≥ 8.0 g/dl (Use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable);
• For females of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to study registration;

You may not qualify if:

• Patients with progressive disease after initial standard systemic therapy
• Patients with oncogene driver mutations
• Patients with more than 5 sites of oligo metastases
• Patients with metastatic lesion size of more than 5 cm
• Patients with more than three metastatic lesion in one organ
• Patients not suitable for definitive radiation therapy to primary disease
• Patients not suitable for ablative radiation therapy to metastatic sites
• Patients with malignant peritoneal disease
• Patients with malignant pleural effusion
• Leptomeningeal disease
• Brain metastases in the brain stem
• Clinical or radiological evidence of spinal cord compression or metastases within 2 mm of spinal cord on MRI
• Severe, active co-morbidity defined as follows:
• Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
• Transmural myocardial infarction within the last 6 months;

Sponsors & Collaborators

• Tata Memorial Hospital: lead

Study Sites (1)

Tata Memorial Hospital, Parel

Mumbai, Maharashtra, 400012, India

RECRUITING

Related Publications (1)

• Tibdewal A, Agarwal JP, Srinivasan S, Mummudi N, Noronha V, Prabhash K, Patil V, Purandare N, Janu A, Kannan S. Standard maintenance therapy versus local consolidative radiation therapy and standard maintenance therapy in 1-5 sites of oligometastatic non-small cell lung cancer: a study protocol of phase III randomised controlled trial. BMJ Open. 2021 Mar 16;11(3):e043628. doi: 10.1136/bmjopen-2020-043628.

  PMID: 33727268 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dr. Anil Tibdewal

  Tata Memorial Hospital, Parel, Mumbai, Maharashtra, India

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Anil Tibdewal

CONTACT

+91-22-24177000; aniltibdewal@gmail.com

Dr. Jai Prakash Agarwal

CONTACT

+91-22-24177000; agarwaljp@tmc.gov.in

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Phase III, Open-label, Randomized controlled trial,

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 14, 2022
• Study Start: April 20, 2020
• Primary Completion: April 20, 2026
• Study Completion (Estimated): April 20, 2028
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)